Alembic Pharma Shares Surge After USFDA Drug Approval, Then Slide

alembic pharma gets usfda nod for generic drug

Shares of Alembic Pharmaceuticals experienced a notable rise of up to 4.13% to Rs 1,135 per share on the Bombay Stock Exchange (BSE) during early morning trading on Tuesday. The boost in share value followed the company’s announcement of receiving final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Betamethasone Valerate Foam, 0.12%.

Betamethasone Valerate Foam is a corticosteroid used for treating scalp conditions such as psoriasis and seborrhea. The foam is a generic version of Luxiq Foam, developed by Norvium Bioscience, LLC. With this recent approval, Alembic Pharmaceuticals’ total number of ANDA approvals from the US FDA has risen to 213, which includes 185 final approvals and 28 tentative approvals.

In its financial performance for the first quarter of fiscal year 2024-25 (Q1FY25), Alembic Pharmaceuticals reported an 11.5% year-on-year increase in profit after tax (PAT), reaching Rs 134 crore. This growth was largely attributed to robust performance in the US market. Revenue from operations grew 4.4% year-on-year to Rs 1,563.8 crore in the June quarter. However, PAT showed a sequential decline of 24.5%, even as the Earnings Before Interest, Tax, Depreciation, and Amortization (EBITDA) margin improved by 14% year-on-year to Rs 239 crore.

The company’s India Branded Business segment saw a 9% increase, totaling Rs 572 crore, with significant growth in specialty therapies such as gynecology, gastrointestinal, anti-diabetic, and ophthalmology. The Animal Health business also performed well, growing by 23% for the quarter.

In the International Business segment, US Generics revenue grew by 18% to Rs 461 crore, driven by two new market launches in the US. Revenue from Ex-US International Formulations increased by 2% to Rs 271 crore, and the company achieved 206 cumulative ANDA approvals.

Despite the initial surge, Alembic Pharmaceuticals’ shares later reversed course, slipping by 1.07% to Rs 1,078.25 per share as of 10:22 AM. This decline occurred while the BSE Sensex edged up by 0.07% to 81,751 levels.

The fluctuations in Alembic’s stock price reflect a broader volatility in market reactions to regulatory news and financial performance updates. As the company continues to expand its product approvals and international market presence, investor sentiment remains closely tied to its operational and financial outcomes.

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hii Aditi Sahu this side..

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